Whitepapers2019-04-19T21:00:41+00:00

Precision BioSciences Deploys Skyland PIMS®

September 14th, 2020|Tags: , , , , , , , , , , , , , , , |

Precision BioSciences (NASDAQ: DTIL) is a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies. With an eye towards therapeutic applications, the company’s ARCUS® genome editing platform has [...]

Understanding Why Skyland PIMS® Was Selected – Novavax

September 11th, 2020|Tags: , , , , , , , , , , |

Headquartered in Gaithersburg, Maryland, Novavax is a late-stage biotechnology company that promotes improved global health through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's vaccine candidates [...]

Optimizing Cell and Gene Therapy Processes & Accelerating Success

September 4th, 2020|Tags: , , , , , , , , , , , , , |

Optimizing Processes & Accelerating Success: In Cell and Gene Therapy Development and Manufacturing Cell and gene therapy companies are rapidly moving toward larger scale manufacturing operations. Their success is highly dependent upon optimizing [...]

Two Steps to Improve Chances of FDA Approval and Maximize Exit Valuations

September 1st, 2020|Tags: , , , , , , , , |

Two Steps to Improve Chances of FDA Approval and Maximize Exit Valuations Very few promising life science discoveries actually result in an approved FDA product. But once your portfolio company clears significant discovery, [...]

Technology Transfer: Shifting the Paradigm to Dynamic and Persistent Process Knowledge Sharing

July 20th, 2020|Tags: , , , , , , , , , |

The goal of technology transfer is defined in ICH Q10 as “[the transfer of] product and process knowledge between development and manufacturing and within manufacturing sites to achieve product realization. This knowledge forms the [...]

The Excel Problem: Picking the Right Tool for Product-Process Data Management

June 19th, 2020|Tags: , , , , , , , |

In the life science industry, like many sectors, Excel is a proverbial hammer. However not all problems are nails. Launched by Microsoft in the 80's, Excel has become ubiquitous as a tool for every [...]

Leader in Restorative Cell Therapies Embeds Skyland PIMS® as Process Knowledge Base from Clinical to Commercial Manufacturing

June 5th, 2020|Tags: , , , , , , |

Overview A leader in the development of restorative cell therapies has a pipeline of products that may offer rapid-onset pain relief and restored function for orthopedic use. With more complex drug manufacturing processes, global [...]

Skyland PIMS® Save Time and Costs in Development and Manufacturing Data Management with Innovative Technology

February 27th, 2020|Tags: , , , , , |

INTRODUCTION Managing disparate data across global manufacturing networks makes capturing, analyzing and sharing process data complex. While process data can be managed manually and with spreadsheets, this approach is error-prone, labor intensive, doesn’t scale [...]

Enabling Data Visibility in Contract Manufacturing Networks

October 23rd, 2019|Tags: , , , , , , |

Life Science manufacturing data management has become increasingly difficult with advancements in complex biotech and “precision” cell and gene therapies. Meanwhile, with performance metrics in manufacturing lagging those in other pharma operations, there’s a [...]